Breast CancerPhase 2NCT03628066
Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer
A Phase 2 study testing Letrozole, Palbociclib and Goserelin in people with Breast Cancer, run by NSABP Foundation Inc at 15 sites in 2 countries.
Trial summary
This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole, Palbociclib and Goserelin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 22 Oct 2018to 30 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be premenopausal. Patients with a hysterectomy: menopausal status must be confirmed by estradiol and FSH.
- Operable hormonal receptor (HR) positive (ER/PR greater than or equal to 10%), HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment and ovarian suppression; HR- positive and HER2-negative as determined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP ) guidelines.
- Diagnostic breast tissue must have an Oncotype DX Breast Recurrence Score® of less than 26 as determined by Genomic Health, Inc.
- No known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib excipients or to endocrine treatments.
- A breast tumor with an ultrasound size of at least 2.0 cm.
- Patients must have the ability to swallow oral medication.
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- ECOG performance status of 0 or 1.
- At the time of randomization, blood counts performed within 2 weeks prior to randomization must meet the following criteria:
- ANC must be greater than or equal to 1500/mm3
- Platelet count must be greater than or equal to 100,000/mm3
- Hemoglobin must be greater than or equal to 10g/dL.
- INR must be within normal limits of the local laboratory ranges. For laboratories that do not report an ULN for the INR assay, use less than or equal to 1.2 as the value for the ULN.
- The following criteria for evidence of adequate hepatic function performed within 2 weeks prior to study entry must be met:
- Total bilirubin must be less than or equal to ULN for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
- Alkaline phosphatase must be must be less than or equal to 1.5 x ULN for the lab; and
- AST and ALT must be less than or equal to 1.5 x ULN for the lab.
- Serum creatinine performed within 2 weeks prior to study entry must be less than or equal to 1.25 x ULN or estimated creatinine clearance greater than or equal to 60 mL/min (as calculated using the method standard for the institutions).
Who cannot join
- Active hepatitis B or hepatitis C with abnormal liver function tests.
- HIV positive patients receiving antivirals.
- Inflammatory/inoperable breast cancer.
- HER2-positive as determined using ASCO-CAP Guidelines.
- Oncotype Dx Breast Recurrence Score® result on diagnostic breast tissue greater than or equal to 26.
- Prior endocrine therapy for breast cancer.
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- Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ).
- Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up such as:
- Active infection or chronic infection requiring chronic suppressive antibiotics;
- Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function;
- Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids);
- Seizure disorders requiring medication.
- Diagnosis by fine needle aspiration (FNA) alone or excisional biopsy or lumpectomy performed prior to study entry.
- Surgical axillary staging procedure prior to study procedure (with exception of FNA or core biopsy).
- Definitive clinical or radiologic evidence of metastatic disease.
- History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with radiotherapy or contralateral invasive breast cancer at any time.
- Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
- Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes. Class III or Class IV myocardial disease as described by the New York Heart Association; a recent history (within 6 months) of myocardial infarction, or symptomatic arrhythmia at the time of randomization.
- Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Such patients are comfortable at rest. Less than ordinary physical activity that causes fatigue, palpitation, dyspnea, or anginal pain.
- Class IV: Patients with cardiac disease resulting in inability to perform any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest.
- The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States11 sites
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
Breast Cancer Care Specialist
Fountain Valley, California, 92708
Orange Coast Blood and Cancer Care
Fountain Valley, California, 92708
Lester and Sue Smith Breast Center
Houston, Texas, 77030
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Coast Hematology-Oncology Associates Medical Group
Long Beach, California, 90806
Long Beach Memorial Medical Center
Long Beach, California, 90806
Oncology Hematology Consultants
Long Beach, California, 90806
Froedtert Hospital
Milwaukee, Wisconsin, 53226
West Virginia University
Morgantown, West Virginia, 26506
Avera Cancer Institute-Sioux Falls
Sioux Falls, South Dakota, 57105
Canada4 sites
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X-3E4
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, H4A 3J1
CHU de Quebec - Hopital de Saint-Sacrement
Québec, Quebec, G1S 4L8
About this study
Official title: An Assessment of the Biological and Clinical Effects of Palbociclib (PD 0332991) With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Patients With Premenopausal Estrogen-Receptor Positive/HER2-Negative Primary Breast Cancer
This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated.
Read the detailed description
NSABP FB-13 is a phase II, open label study to examine the biological and clinical effect of neoadjuvant endocrine therapy with letrozole, palbociclib and ovarian suppression in premenopausal patients with estrogen-receptor (ER) positive, HER2-negative, early invasive breast cancer.
Premenopausal women newly diagnosed with ER-positive/HER2-negative early breast cancer who are suitable candidates for neoadjuvant endocrine therapy will be invited to join the FB-13 trial. A screening Oncotype DX Breast Recurrence Score® will be performed by Genomic Health, Inc. (GHI) on the diagnostic tissue of consenting patients to verify eligibility.
Patients will be stratified into one of two approximately equal sized cohorts based on baseline Breast Recurrence Score (RS) (cohort 1: patients with RS less than 11 or cohort 2: patients with RS 11 to less than 26).
Patients in both cohorts will receive letrozole 2.5 mg by mouth daily, palbociclib 125 mg by mouth daily for 21 days of a 28 day cycle, and goserelin 3.6 mg subcutaneous injection on Day 1 of each 28 day cycle. At Week 6 of study therapy, patients will have two core-cut biopsies. Patients from both cohorts who have a Ki67 less than 10% level will continue receiving study therapy for a total of 6 cycles. Patients with a persistent Ki67 greater than or equal to 10% at week 6 will permanently discontinue study therapy and begin neoadjuvant chemotherapy or proceed to surgery at the discretion of the treating physician.
Pre-treatment samples and post-surgical samples will be collected and analysed to identify subgroups of patients who may derive the most clinical benefit. The results of the biological analyses may allow a target sensitive population to be selected for future trials. The tissue collected in FB-13 will form an integral part of the primary analyses; so all core biopsies in this trial will be mandated for patients.
Two core-cut biopsies will be collected from each patient at baseline, after 6 weeks of study therapy, and upon completion of study therapy (24 weeks) at the time of definitive surgery.
Blood samples will be collected at baseline, 4 weeks, and at 24 weeks for estrone and estradiol levels to demonstrate ovarian suppression. A 4-week estradiol level in the postmenopausal range will be required to receive further treatment on study.
- Conditions
- Breast Cancer
- Being tested
- Letrozole, Palbociclib, Goserelin, Oncotype DX Breast Recurrence Score
- Keywords
- Ovarian Suppression, Neoadjuvant, Premenopausal, Estrogen-Receptor Positive, HER2-Negative, Primary, Palbociclib, Letrozole, Goserelin, Ki67, Oncotype DX Breast Recurrence Score, Open-Label
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
Letrozole 2.5 mg by mouth daily for 24 weeks
PalbociclibDrug
Also called Ibrance
Palbociclib 125mg by mouth daily for 21 days per 28-day cycle (21 days on, 7 days off) for 24 weeks
GoserelinDrug
Also called Zoladex
Goserelin 3.6mg subcutaneous injection x 1 on Day 1 of each 28-day cycle for 24 weeks
Oncotype DX Breast Recurrence ScoreDiagnostic test
Prior to assignment to Arm 1 the Oncotype DX diagnostic test will be conducted on diagnostic tissue to assign a recurrence score for stratification to cohort 1 or 2.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Oncotype DX Breast recurrence score on diagnostic tissue
Daily Letrozole for 24 weeks + Palbociclib daily for 24 weeks + Goserelin weekly for 24 weeks Receives: Drug: Letrozole; Drug: Palbociclib; Drug: Goserelin; Diagnostic Test: Oncotype DX Breast Recurrence Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cell cycle arrest
Percentage of patients with a Ki67 less than 2.7%
Measured: From study entry to the time of the 6 week tumor biopsy to assess Ki67, approximately 6 weeks
Secondary outcomes (9)
Objective response rate
Objective response rate determined by breast tumor assessment measured by clinical exam and ultrasound
Measured: From study entry to the 24 week clinical assessment/ultrasound, approximately 24 weeks
Pathologic complete response to study therapy (breast)
Percentage of patients with absence of invasive cancer in surgical specimens
Measured: From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks
Pathologic complete response to study therapy (breast with nodes)
Percentage of patients with absence of invasive cancer in surgical specimens
Measured: From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks
Correlation between Oncotype DX Breast Recurrence Score® and clinical Complete Response (cCR)
Correlation of the Oncotype DX Breast Recurrence Score® with clinical Complete Response
Measured: From study entry to the 24 week clinical assessment/ultrasound, approximately 24 weeks
Correlation between Oncotype DX Breast Recurrence Score® and pathologic Complete Response (pCR)
Correlation of the Oncotype DX Breast Recurrence Score® with pathologic Complete Response
Measured: From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks
Correlation between Oncotype DX Breast Recurrence Score® and Complete Cell cycle arrest rate (CCAR)
Correlation of the Oncotype DX Breast Recurrence Score® with Complete Cell cycle arrest rate
Measured: From the time of study entry to time of the 6-week tumor biopsy to assess Ki67, approximately 6 weeks
Comparison between surgical intent and surgery received
Changes between surgical intent declared at study start and actual surgery received after treatment
Measured: From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks
Comparison of estrone levels
Compare the estrone level at baseline to that after neoadjuvant treatment
Measured: From study entry to the 4 week blood draw, approximately 4 weeks
Comparison of estradiol levels
Compare the estradiol level after neoadjuvant treatment
Measured: From study entry to the 4 week blood draw, approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start22 Oct 2018
- Primary completion30 Nov 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- Genomic Health®, Inc., Pfizer
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628066
- Sponsor's protocol ID
- NSABP FB-13
- Status last verified
- Apr 2022
- First submitted
- 27 Jul 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Biological and Clinical Effects of Palbociclib (PD 0332991) With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Patients With Premenopausal Estrogen-Receptor Positive/HER2-Negative Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT03628066
- Acronym / sponsor ID
- NSABP FB-13
- Conditions
- Breast Cancer
- Keywords
- Ovarian Suppression, Neoadjuvant, Premenopausal, Estrogen-Receptor Positive, HER2-Negative, Primary, Palbociclib, Letrozole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- Genomic Health®, Inc., Pfizer
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated.
Detailed description
NSABP FB-13 is a phase II, open label study to examine the biological and clinical effect of neoadjuvant endocrine therapy with letrozole, palbociclib and ovarian suppression in premenopausal patients with estrogen-receptor (ER) positive, HER2-negative, early invasive breast cancer.
Premenopausal women newly diagnosed with ER-positive/HER2-negative early breast cancer who are suitable candidates for neoadjuvant endocrine therapy will be invited to join the FB-13 trial. A screening Oncotype DX Breast Recurrence Score® will be performed by Genomic Health, Inc. (GHI) on the diagnostic tissue of consenting patients to verify eligibility.
Patients will be stratified into one of two approximately equal sized cohorts based on baseline Breast Recurrence Score (RS) (cohort 1: patients with RS less than 11 or cohort 2: patients with RS 11 to less than 26).
Patients in both cohorts will receive letrozole 2.5 mg by mouth daily, palbociclib 125 mg by mouth daily for 21 days of a 28 day cycle, and goserelin 3.6 mg subcutaneous injection on Day 1 of each 28 day cycle. At Week 6 of study therapy, patients will have two core-cut biopsies. Patients from both cohorts who have a Ki67 less than 10% level will continue receiving study therapy for a total of 6 cycles. Patients with a persistent Ki67 greater than or equal to 10% at week 6 will permanently discontinue study therapy and begin neoadjuvant chemotherapy or proceed to surgery at the discretion of the treating physician.
Pre-treatment samples and post-surgical samples will be collected and analysed to identify subgroups of patients who may derive the most clinical benefit. The results of the biological analyses may allow a target sensitive population to be selected for future trials. The tissue collected in FB-13 will form an integral part of the primary analyses; so all core biopsies in this trial will be mandated for patients.
Two core-cut biopsies will be collected from each patient at baseline, after 6 weeks of study therapy, and upon completion of study therapy (24 weeks) at the time of definitive surgery.
Blood samples will be collected at baseline, 4 weeks, and at 24 weeks for estrone and estradiol levels to demonstrate ovarian suppression. A 4-week estradiol level in the postmenopausal range will be required to receive further treatment on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Letrozole, Drug: Palbociclib, Drug: Goserelin, Diagnostic Test: Oncotype DX Breast Recurrence ScoreOncotype DX Breast recurrence score on diagnostic tissue Daily Letrozole for 24 weeks + Palbociclib daily for 24 weeks + Goserelin weekly for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must be premenopausal. Patients with a hysterectomy: menopausal status must be confirmed by estradiol and FSH.
- Operable hormonal receptor (HR) positive (ER/PR greater than or equal to 10%), HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment and ovarian suppression; HR- positive and HER2-negative as determined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP ) guidelines.
- Diagnostic breast tissue must have an Oncotype DX Breast Recurrence Score® of less than 26 as determined by Genomic Health, Inc.
- No known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib excipients or to endocrine treatments.
- A breast tumor with an ultrasound size of at least 2.0 cm.
Key exclusion criteria (21 listed)
- Active hepatitis B or hepatitis C with abnormal liver function tests.
- HIV positive patients receiving antivirals.
- Inflammatory/inoperable breast cancer.
- HER2-positive as determined using ASCO-CAP Guidelines.
- Oncotype Dx Breast Recurrence Score® result on diagnostic breast tissue greater than or equal to 26.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleAlso: FemaraLetrozole 2.5 mg by mouth daily for 24 weeks | Drug | Arm 1 |
| PalbociclibAlso: IbrancePalbociclib 125mg by mouth daily for 21 days per 28-day cycle (21 days on, 7 days off) for 24 weeks | Drug | Arm 1 |
| GoserelinAlso: ZoladexGoserelin 3.6mg subcutaneous injection x 1 on Day 1 of each 28-day cycle for 24 weeks | Drug | Arm 1 |
| Oncotype DX Breast Recurrence ScorePrior to assignment to Arm 1 the Oncotype DX diagnostic test will be conducted on diagnostic tissue to assign a recurrence score for stratification to cohort 1 or 2. | Diagnostic test | Arm 1 |
Primary outcome
Complete Cell cycle arrest
Time frame: From study entry to the time of the 6 week tumor biopsy to assess Ki67, approximately 6 weeks
Percentage of patients with a Ki67 less than 2.7%
9 secondary outcomes
Objective response rate
Time frame: From study entry to the 24 week clinical assessment/ultrasound, approximately 24 weeks
Pathologic complete response to study therapy (breast)
Time frame: From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks
Pathologic complete response to study therapy (breast with nodes)
Time frame: From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks
Correlation between Oncotype DX Breast Recurrence Score® and clinical Complete Response (cCR)
Time frame: From study entry to the 24 week clinical assessment/ultrasound, approximately 24 weeks
Correlation between Oncotype DX Breast Recurrence Score® and pathologic Complete Response (pCR)
Time frame: From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks
Correlation between Oncotype DX Breast Recurrence Score® and Complete Cell cycle arrest rate (CCAR)
Time frame: From the time of study entry to time of the 6-week tumor biopsy to assess Ki67, approximately 6 weeks
Comparison between surgical intent and surgery received
Time frame: From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks
Comparison of estrone levels
Time frame: From study entry to the 4 week blood draw, approximately 4 weeks
Comparison of estradiol levels
Time frame: From study entry to the 4 week blood draw, approximately 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole, Palbociclib and Goserelin in people with Breast Cancer, run by NSABP Foundation Inc at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Cell cycle arrest (time frame: From study entry to the time of the 6 week tumor biopsy to assess Ki67, approximately 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.